JP2012523281A - Apparatus for organ-specific inflammation treatment - Google Patents

Abstract

A method and device for delivering a cardiac treatment is described, and the implantable device for delivering the cardiac treatment is additionally configured to detect the presence of inflammation. Based on the detection of inflammation, the device can be configured to modify its treatment delivery in various ways and / or communicate information to other agents for other types of treatment interventions.
[Selection] Figure 4

Description

The present invention relates to apparatus and methods for the treatment and detection of diseases, particularly heart disease, and further to devices that apply electrical stimulation to the heart, such as cardiac pacemakers.
(Claiming priority)
The benefit of priority based on US Provisional Patent Application No. 61 / 167,280, filed April 7, 2009, incorporated herein by reference, is claimed herein.
(Cross-reference of related applications)
This application is related to US Provisional Patent Application No. 61 / 099,251, filed September 23, 2008, which is incorporated herein by reference.

  Heart failure (HF) is a debilitating disease that refers to a clinical syndrome in which abnormal cardiac function causes subnormal cardiac output that can be below levels adequate to meet the metabolic demands of peripheral tissues. . Although heart failure can be caused by a variety of causes, the most common is ischemic heart disease. Heart failure is usually treated with a regimen designed to enhance cardiac function and / or alleviate symptoms of depression.

US patent application Ser. No. 11 / 860,957 US Patent Application No. 61 / 090,485 U.S. Patent Application No. 11 / 689,032 US patent application Ser. No. 11 / 687,957

  Ventricular electrical stimulation can also be useful in the treatment of heart failure. Some heart failure patients suffer from intraventricular and / or interventricular conduction disturbances (eg leg blocks) and thus increase their cardiac output by using electrical stimulation to improve the synchronization of ventricular contractions It has been shown that can be made. In an attempt to improve the coordination of atrial and / or ventricular contractions to treat these disorders, appropriately timed electricity in one or more heart chambers called cardiac resynchronization therapy (CRT) Implantable cardiac devices that apply stimuli have been developed. Ventricular resynchronization is useful for the treatment of heart failure because it is not directly inotropic, but resynchronization results in more cooperative ventricular contractions to improve pump efficiency and increase cardiac output. It is because it increases. Currently, in the most common form of CRT, after a specific atrial-ventricular delay interval for detection of intrinsic atrial contraction or delivery of atrial pacing, a stimulation pulse is applied to both ventricles simultaneously or at a specific biventricular offset interval. Add. Other types of electrical stimulation by enhancing myocardial contractility may also be useful for improving cardiac function in HF patients.

  Heart failure is also a disease characterized in part by immune activation and inflammation. Thus, HF patients have high levels of inflammatory cytokines both within the circulation and within the failing heart itself. Coronary artery disease (atheroma plaque) often seen in HF patients is also associated with inflammation. Such inflammation can have an impact on how the various heart therapies delivered by the implantable device function and may indicate the need to modify how the treatment is administered.

2 illustrates the physical configuration of an exemplary pacing device. Fig. 3 illustrates components of an exemplary device. FIG. 3 is a block diagram of an exemplary device electronic circuit. Fig. 4 illustrates an exemplary treatment algorithm incorporating detection of inflammation.

  Described herein are methods and devices for administering cardiac therapy, wherein the implantable device for administering cardiac therapy is additionally configured to detect the presence of inflammation. Based on the detection of inflammation, the device can be configured to modify its treatment delivery in various ways and / or communicate information to other agents for other types of treatment interventions. (Implantable devices can also be configured to deliver other types of organ-specific treatments that are coordinated by detection of inflammation). Described below are different types of heart therapies that can be administered by a heart device, techniques that allow the device to detect inflammation, and modifying different types of heart therapies in response to detection of inflammation. A possible method and an exemplary hardware platform.

Inflammation Detection Inflammation in a particular organ typically results in an increase in extravascular fluid within the affected tissue, which is drained by the lymphatic system. The lymphatic circulation begins with highly permeable capillary lymph vessels that drain the lymph into larger contractile lymph vessels with valves and smooth muscle walls. The functional unit of the lymphatic vessel is the segment between the two valves, known as the lymph anion. Lymph anions have contractility that depends on the ratio of radius to length to wall thickness. An increase in the rate of contraction of lymph anions indicates an increase in lymph flow and thus the presence of inflammation. An increase in the size of the lymph nodes from which lymphatic vessels are drained can also be used to detect inflammation.

  The implantable device described herein incorporates an inflammatory sensor that detects information related to the contraction of lymph anions or the dimensions of lymph anions or lymph nodes. In one embodiment, a cardiac device comprising an inflammation sensor adjusts the treatment delivery based on the detection of inflammation. As described below, such treatment adjustments may require changes in the parameter values used to administer the treatment and the choice of specific treatment. In another embodiment, the inflammatory sensor is incorporated into a cardiac rhythm management system with a processor designed to look for trends in lymphangione contraction information. Algorithms that use sensor information can detect decompensation events and provide alerts via the patient management system, where the information is communicated to the patient management server or other location via telemetry and network communications. Algorithms that use sensor information can also track inflammatory responses to various types of cardiac therapies, such as cardiac resynchronization therapy, and suggest changes in treatment optimization programming. If there are conditions that can cause inflammation, certain prophylactic heart therapies (such as intermittent pacing described below) may be suspended to prevent further exacerbating secondary diseases. The aforementioned inflammation monitoring can also be used to warn of vulnerable plaque or pocket infections, to monitor overall inflammation, and to monitor Crohn's disease and asymptomatic hepatitis.

  Inflammation sensors described herein can detect the contraction of lymph anions, or the size of lymph anions or lymph nodes, to determine the upstream inflammation (ie, inflammation in a particular organ that is excreted by a particular lymph anion). ). An increase in the contraction rate and / or size (ie, contractile force) of lymph anions can be an indication of inflammation. The contraction of lymph anions can be, for example, 1) a change in the size of the lymph anion or lymph node (increase in diameter, increase in strain), 2) a change in pressure (increase in interstitial pressure), 3) the lymph anion wall Changes in thickness (optical), 4) video recording of downward deflection, 5) changes in impedance of lymph anions, 6) myoelectric potential of lymph anions, and the like can be detected. The lymph sensor for detecting one or more of the variables listed above may be one or more electrodes, light sensors, pressure sensors, or acoustic sensors. The sensor can be connected to the implantable device's housing and electronic circuitry via an implantable lead, or it can be an accompanying device in wireless communication with the implantable device. To detect inflammation, the lymph sensor signal can be compared to a specified threshold. The amount of inflammation present can also be quantified from the lymph sensor signal according to a specified measure.

Response by different types of heart therapy to inflammation detection The most common type of electrical stimulation therapy administered by implantable cardiac devices is the pacing applied to selected heart chambers to treat heart rhythm disorders It is a therapy. For example, a pacemaker is a cardiac rhythm management device that paces the heart with timed pacing pulses. The most common condition for which pacemakers are used is in the treatment of bradycardia where the ventricular rate becomes too low. Permanent or intermittent atrial-ventricular conduction disturbances (ie AV block) and sinus failure syndromes represent the most common causes of bradycardia, which require permanent pacing. obtain. If functioning properly, the pacemaker will artificially enforce the ability of the heart that cannot be paced on its own to force a minimum heart rate and / or AV conduction at an appropriate rhythm to meet metabolic demands. Make up by recovering. As mentioned above, pacing therapy can also be used to treat cardiac conduction disorders to improve systolic cooperation, which is called cardiac resynchronization therapy. Other cardiac rhythm management devices detect atrial and / or ventricular tachyarrhythmias and apply electrical stimulation to detect tachyarrhythmias in the form of cardioversion / defibrillation shock or anti-tachycardia pacing. Designed to disappear. Certain combination devices can incorporate all of the functions described above. Any device having a pacing function is referred to herein simply as a pacemaker, regardless of the other functions it can perform.

  Another form of electrical stimulation therapy that can be applied by an implantable device is neural stimulation of nerves that govern the heart, such as the vagus or sympathetic nerves. For example, the vagus nerve provides parasympathetic stimulation to the heart, which is beneficial when blood supply to the heart is compromised and diminishes the effects of increased sympathetic activity. Stimulation of the vagus nerve at the prenodal or postnodal site results in coronary artery dilation and a reduction in workload on the heart due to its effect on myocardial contractility.

  It has also been demonstrated that electrical stimulation pulses can be applied to the heart in a manner that can enhance myocardial contractility, sometimes referred to as myocardial contractility regulation (CCM). Applying a contractility enhancing stimulus to the ventricle can therefore aid in the treatment of heart failure. Because contractile augmentation stimuli can be applied during the refractory period after intrinsic contraction, they become non-excitable stimuli. Such stimulation is presumed to increase myocardial contraction by increasing intracellular calcium concentration and / or inducing neurotransmitter release. However, contractility enhancing stimuli can also be applied in an excitatory manner, referred to herein as high volume pacing (HOP). In one form of HOP, stimulation is applied in the same manner as conventional pacing using a bradycardia pacing mode that uses stimulation pulses with higher stimulation energy. For example, a stimulation pulse for high volume pacing is a biphasic (or polyphasic) waveform with a + or-5-8 volt apex voltage amplitude and a pulse duration of 20-70 milliseconds. be able to. In another form of HOP, similar stimulation pulses are applied during the refractory period following conventional ventricular pacing pulses. A further description of a device that can be administered HOP therapy and incorporate the subject matter of this application is described in US Pat. No. 6,037,034, filed on Sep. 25, 2007, assigned to the present applicant, incorporated herein by reference. And in US Pat.

  Another form of electrical stimulation therapy is administered in a manner that advantageously redistributes myocardial stress during systole for therapeutic purposes, for example in the treatment of patients with ischemic heart disease, post-MI patients, and HF patients. Pacing. Myocardial regions that contract early during systole experience lower wall stress than regions that contract late. A pacing pulse, in addition to a specific myocardial region during systole, pre-excites that region to other regions, causing other regions to be excited by intrinsic activation or subsequent pacing pulses be able to. (The term pacing pulse as used herein is any type of electrical stimulation that excites the myocardium, regardless of whether it is used to force a specific pace). Compared to intrinsic contraction, areas that are pre-excited are mechanically unloaded or stress-released, while areas that are subsequently excited are subjected to increased stress. Such pre-excitation pacing can be applied to intentionally relieve certain myocardial regions that may be expected to suffer deleterious remodeling, such as areas around myocardial infarction or hypertrophic regions. Pre-excitation pacing can also be applied to intentionally stress regions away from the pre-excitation pacing site to provide a conditioning effect similar to the beneficial effects of exercise. For either intentional stress application or stress release to the myocardial region, such pre-excitation pacing for cardioprotection is intermittently performed according to a fixed schedule or based on detection of a specified start or end condition. Which is referred to herein as intermittent pacing therapy or IPT. A further description of devices that can be subjected to IPT and can incorporate the subject matter of this application is described in US Pat. It is found in Patent Document 4 filed on March 19, 1980.

  As described above, detection of inflammation can indicate the need to modify the therapy administered by the cardiac device. Because inflammation can affect myocardial tissue capture thresholds, devices that apply pacing stimuli (ie, electrical stimuli that cause myocardial contraction) increase pulse energy based on detection of inflammation (eg, pacing (By increasing the amplitude or duration of the pulse). It has also been shown that inflammation can affect how a patient responds to CRT treatment. Thus, the CRT device may modify the therapy by changing CRT parameters (eg, atrial-ventricular delay or biventricular offset interval) based on the detection of inflammation, or by starting or stopping a particular therapy mode. Can be programmed. Inflammation can also indicate an ischemic event against which neural stimulation or certain types of cardiac stimulation can be beneficially initiated. It has also been found that inflammation can increase the likelihood of sudden cardiac death in certain patients. Thus, devices configured to deliver anti-tachycardia therapy such as cardioversion / defibrillation shock or anti-tachycardia pacing can detect tachycardia by lowering the tachycardia threshold based on the detection of inflammation. Can be programmed to increase sensitivity and decrease specificity.

  What has been described above is a device that modifies treatment based on detection of inflammation. A device configured to deliver a variable amount of therapy can also be configured to modify the amount based on a quantized measure of the abundance of inflammation derived from the lymph sensor signal. For example, a device that provides a specific treatment mode (eg, intermittent pacing therapy, CRT, neural stimulation, HOP) according to a timed duty cycle can be programmed to increase or decrease the duty cycle according to the amount of inflammation detected. Can do. The device can also be programmed to use the amount of inflammation detected as a feedback variable to adjust treatment parameters. For example, the device may provide a CRT with a specified set of treatment parameters (ie, parameters related to pulse energy, pulse timing, and / or treatment duty cycle) as long as the inflammation level remains constant or decreases. IPT, HOP, and / or neural stimulation can be added, but the parameters can be adjusted if inflammation increases.

Exemplary Cardiac Device FIG. 1 shows an implantable cardiac pacing device 100 for administering any type of pacing therapy described above. Implantable pacing devices are typically placed subcutaneously or submuscularly in the patient's chest, with leads leading through the vein into the heart and connecting the device to electrodes placed in the heart chamber This electrode is then used for detection and / or pacing. The electrodes can also be placed on the epicardium by various means. A programmable electronic controller causes pacing pulses to be output in response to the passage of time intervals and / or detected electrical activity (ie, an intrinsic heartbeat that is not the result of a pacing pulse). The device detects the heart's intrinsic electrical activity through one or more detection channels, each incorporating one or more electrodes. To activate myocardial tissue in the absence of endogenous beats, a pacing pulse having energy above a certain threshold is applied to one or more pacing sites, each with one or more electrodes. Are added through one or more pacing channels. FIG. 1 shows an exemplary device having two leads 200 and 300, each of which is a multipolar (ie, multielectrode) lead having electrodes 201-203 and 301-303, respectively. Electrodes 201-203 are placed in the right ventricle to stimulate or detect the right ventricular or septal region, while electrodes 301-303 are placed in the coronary sinus to stimulate or detect the region of the left ventricle Is done. In other embodiments, any number of electrodes in the form of monopolar and / or multipolar leads can be used to detect or stimulate various myocardial sites. When the device and lead are implanted, the stimulation and / or detection channel of the device is configured to selectively stimulate or detect one or more specific myocardial sites with selected electrodes in the multi-electrode. Can be configured. The stimulation channel can be used to apply conventional bradycardia pacing, CRT, HOP therapy, intermittent stress-enhancing pacing therapy, and / or neural stimulation.

  FIG. 2 shows the components of the implantable device 100 in more detail. The implantable device 100 includes a hermetically sealed housing 130 that is placed subcutaneously or submuscularly in the patient's chest. The housing 130 can be formed from a conductive metal such as titanium and can serve as an electrode for applying electrical stimulation or for sensing in a monopolar configuration. Mounted on the housing 130 is a header 140, which can be formed of an insulating material, which receives the leads 200 and 300 and then electrically connects the leads to the pulse generation circuit and / or the sensor circuit. it can. Housed within housing 130 is an electronic circuit 132 that provides functionality to the device as described herein, which controls the operation of the power supply, detection circuit, pulse generation circuit, and device. A programmable electronic controller and a telemetry transceiver that can communicate with an external programmer or remote monitoring device can be included.

  FIG. 3 shows a system diagram of the electronic circuit 132. The battery 22 supplies power to the circuit. The controller 10 controls the overall operation of the device, including decisions about the time and mode of stimulation pulses through the stimulation channel, according to programmed instructions and / or circuitry. The controller can be implemented as a microprocessor and a microprocessor-based controller including a memory for storing data and programs, and can be implemented using dedicated hardware components such as an ASIC (eg, a finite state machine). Or a combination thereof. The controller also includes a timing circuit, such as an external clock, that implements a timer that is used to measure the passage of time intervals and schedule events. As used herein, the term controller programming refers to the specific configuration of code that is executed by a microprocessor or hardware component that performs a particular function. Interfacing to the controller is a detection circuit 30 and a pulse generation circuit 20, which allow the controller to interpret the detection signal and control the delivery of pacing and / or other stimulation pulses according to a pacing mode. The controller can operate the device in a number of programmed pacing modes that define how to output pulses in response to detected events and the end of the time interval. The controller also implements a timer derived from an external clock signal to keep track of time and perform real-time operations such as the scheduled start of a particular type of treatment mode.

  The detection circuit 30 receives an atrial and / or ventricular electrocardiogram signal from a detection electrode, and includes a detection amplifier, an analog / digital converter for digitizing a detection signal input from the detection amplifier, and a detection amplifier. And a writable register for gain and threshold adjustment. The pacemaker's detection circuit detects cardiac chamber or atrial sense when an electrocardiogram signal generated by a particular channel (ie, a voltage representative of cardiac electrical activity detected by an electrode) exceeds a specified detection threshold. Detect ventricular sense. The pacing algorithm used for a particular pacing mode uses such a sense to initiate or suppress pacing, and the intrinsic atrium and / or ventricular rate is between the atrial sense and the ventricular sense, respectively. It can be detected by measuring the time interval. The pulse generation circuit 20 applies conventional pacing, HOP, or other stimulation pulses to electrodes placed within or elsewhere in the heart and controls the capacitive discharge or current source pulse generator and the pulse generator. And registers for adjusting parameters such as pulse energy (eg, pulse amplitude and width). The pulse generation circuit may also include a shock pulse generator for applying cardioversion / defibrillation shock via the shock electrode based on the detection of tachycardia.

  A telemetry transceiver 80 is interfaced to the controller, which allows the controller to communicate with external devices such as external programmers and / or remote monitoring units. The external programmer is a computer controlled device having an associated display and input means that can query the pacemaker and receive stored data and directly adjust the pacemaker operating parameters. The external device can also be a remote monitoring unit that interfaces to a patient management network to allow the implantable device to send data and alert messages to clinical staff over the network and Can allow remote programming of mold devices. The network connection between the external device and the patient management network can be implemented, for example, via an internet connection, over a telephone line, or via a mobile phone wireless link. This embodiment is also illustrated so that the switch 24 can be interfaced to the controller so that the patient can send a signal of a specific condition or event to the implantable device. In different embodiments, the switch 24 can be actuated via telemetry magnetically, tactilely, or by hand-held alerting device or the like. The controller can be programmed to use the actuation of switch 24 as a start and / or end condition to initiate a particular treatment mode.

The stimulation channel consists of a pulse generator connected to the electrode, while the detection channel consists of a sense amplifier connected to the electrode. Shown are electrodes 40 ₁ to 40 _N , where N is an integer. The electrodes can be on the same or different leads and are electrically connected to the MOS switch matrix 70. The switch matrix 70 is controlled by the controller and is used to switch selected electrodes to the sense amplifier input or to the pulse generator output to configure the detection channel or pacing channel, respectively. . The device can be equipped with any number of pulse generators, amplifiers, and electrodes, any of which can be combined to form a detection channel or pacing channel. Thus, the device can apply ventricular pacing and / or other types of stimulation to a single site or multiple sites. The switch matrix 70 also allows selected electrodes of the available buried electrodes to be incorporated into the detection and / or pacing channel in a monopolar or bipolar configuration. Bipolar detection or pacing configuration refers to the detection of a potential between two closely spaced electrodes or the output of a pacing pulse, where the two electrodes are typically on the same lead (eg, a bipolar lead). 2 selected electrodes of wire ring and tip electrode, or multipolar lead). A unipolar detection or pacing configuration is when the potential detected by an electrode or the output pacing pulse is referenced to a conductive device housing or another remote electrode.

  The device may also include one or more physiological detection modalities 25 for use in, for example, pacing rate, stimulation parameter optimization, and / or control of starting / stopping particular treatment modes. One such detection modality allows the controller to detect changes in patient physical activity, detect patient posture (ie, using a multi-axis accelerometer), and / or detect heart sounds It is an accelerometer. Dedicated acoustic sensors, which can be of various types, can also be used to detect heart sounds. The impedance sensor can be configured with electrodes for measuring minute ventilation for use in heart rate sensitive pacing and / or for measuring heart stroke volume or cardiac output. . The device can also include a pressure sensor that can be used, for example, to measure pressure in the pulmonary artery or elsewhere.

  The device also includes an inflammation sensor 26 for detecting the presence of inflammation to detect inflammation in a particular organ such as the heart. The sensor 26 can be connected to the controller 10 via an implantable lead or can be incorporated into an implantable accessory device that is in wireless communication with the controller 10. Inflammation sensor 26 may be one or more electrodes for detecting myoelectric potential or measuring impedance, an optical or acoustic sensor for detecting the size or change in size of lymph anions or lymph nodes, or A pressure sensor may be included for detecting the fluid pressure within the lymph anion or lymph node.

Exemplary Embodiment In an exemplary embodiment, the implantable device includes an inflammation sensor for detecting a physical property of a lymph anion or lymph node, the inflammation sensor being a signal generated by the inflammation sensor. And interfaced to a controller configured to detect the presence of inflammation. The device also includes a detection and stimulation channel for detecting cardiac activity and applying electrical stimulation to one or more myocardial or neural sites, where the controller includes one or more specific treatment modes And is configured to apply electrical stimulation via one or more stimulation channels. The controller is additionally programmed to modify the application of electrical stimulation when inflammation is detected.

  In various specific embodiments that can be combined, the inflammation sensor can be configured to detect the size of a lymph anion or lymph node, in which case the controller detects inflammation when the size exceeds a specified threshold. The inflammatory sensor can be programmed to detect, or the inflammatory sensor can be configured to detect the contraction of lymph anions, in which case the controller has a contraction rate and / or contraction force of the lymph anions that exceeds a specified threshold. Programmed to detect inflammation. Lymphangion contraction can be caused, for example, by an increase in diameter, a change in mechanical strain, a change in pressure due to an increase in interstitial pressure, a change in optically measured lymphangion wall thickness, video recording, etc. This can be detected by measuring a change in the size of the lymph anion, such as a change in downward deflection detected, a change in the impedance of the lymph anion, or a myoelectric potential of the lymph anion. The inflammatory sensor can be, for example, one or more electrodes for detecting myoelectric potential, an electrical impedance sensor, an acoustic transducer, or an optical sensor.

  The implantable device can further comprise a telemetry unit for receiving input from the external device, in which case the controller is configured to detect inflammation based on the signal from the inflammation sensor and the input received from the external device. Further programmed to detect presence. The telemetry unit can also be used to issue an alert to an external device such as an external patient management system based on the detection of inflammation.

  The therapy administered by the device can be bradycardia pacing, cardiac resynchronization pacing, intermittent pacing therapy, contractility augmentation pacing, and neural stimulation. The controller can be programmed to increase the amplitude or duration of the stimulation pulse used for any of these treatment modes based on the detection of increased inflammation. If the particular treatment mode is a contractile augmentation stimulus (eg, high stroke pacing, anodic pacing, or refractory period stimulation), the controller may apply the contractile augmentation stimulus based on the detection of increased inflammation. It can be programmed to start or otherwise increase its extent. If the particular treatment mode is intermittent stress-enhancing pacing, the controller may stop or otherwise reduce the extent of the intermittent stress-enhancing pacing based on the detection of increased inflammation. Can be programmed. If the particular treatment mode is cardiac resynchronization pacing, the controller reoptimizes pacing parameters selected from the group including an atrial-ventricular delay interval and a biventricular offset interval based on detection of inflammation. Can be programmed. If the particular mode of treatment is an anti-tachycardia therapy selected from the group including the delivery of cardioversion / defibrillation shock in response to tachycardia detection and the delivery of anti-tachycardia pacing The controller is programmed to lower the tachycardia threshold for detecting tachycardia based on detection of increased inflammation and / or to increase the tachycardia threshold based on detection of decreased inflammation be able to. In any of the specific treatment modes described above, the controller can also be programmed and / or reduced to make temporary adjustments to the treatment mode made in response to increased inflammation. If a level of inflammation is detected, other treatment parameters such as pacing or duty cycle can be programmed to adjust backwards.

  FIG. 4 illustrates an exemplary treatment algorithm that incorporates detection of inflammation. In step A4, the device operates to monitor for the presence of inflammation in step A2 at the same time that the treatment is administered in a particular treatment mode. If inflammation is detected, in step A3, the device issues a warning to the patient management system via telemetry. The particular treatment is also modified in step A4 by any of the methods described above and then returns to step A1.

  The invention has been described with the specific embodiments described above. It should also be appreciated that these embodiments can also be combined in any way deemed advantageous. Numerous alternatives, variations, and modifications will also be apparent to those skilled in the art. Such other alternatives, variations, and modifications are intended to fall within the scope of the appended claims.

10: controller 20: pulse generation circuit 22: battery 24: switch 25: physiological sensor 26: inflammation sensor 30: detection circuit 40, 201-203, 301-303: electrode 70: switch matrix 80: telemetry transceiver 100: Implantable cardiac pacing device 130: housing 132: electronic circuit 140: header 200, 300: lead wire

Claims (15)

A detection and stimulation channel for detecting cardiac activity and applying electrical stimulation to one or more myocardium or nerve sites;
A controller configured to apply electrical stimulation via one or more pacing channels according to one or more specific treatment modes;
An inflammatory sensor for detecting the physical properties of lymph anions or lymph nodes;
With
The controller is configured to detect the presence of inflammation from a signal generated by the inflammation sensor;
The controller is programmed to modify the application of the electrical stimulus when inflammation is detected;
An implantable device characterized by that.   The inflammation sensor is configured to detect a dimension of lymph anion or lymph node, and the controller is programmed to detect inflammation when the dimension exceeds a specified threshold. The implantable device of claim 1.   The implantable device of claim 1, wherein the inflammatory sensor is configured to detect lymphangione contraction.   The implantable device of claim 3, wherein the controller is programmed to detect inflammation when the contraction rate of the lymph anion exceeds a specified threshold.   4. The implantable device according to claim 3, wherein the controller is programmed to detect inflammation when the contraction force of the lymph anion exceeds a specified threshold.   The inflammatory sensor may have a size change, such as an increase in the diameter of the lymph anion, a change in pressure due to a change in mechanical strain, an increase in interstitial pressure, etc., and an optically measured lymph anion wall thickness. Detecting the contraction of the lymph anion by measuring a change, a downward deflection detected through video recording, a change in impedance of the lymph anion, or an action potential of the detected lymph anion The implantable device according to claim 3, wherein the implantable device is configured as follows.   The inflammatory sensor is of a type selected from the group comprising one or more electrodes for detecting myoelectric potential, an electrical impedance sensor, an acoustic transducer, and an optical sensor. Item 2. The implantable device according to Item 1.   A telemetry unit for receiving an input from an external device, wherein the controller detects the presence of the inflammation based on a signal from the inflammation sensor and an input received from the external device; 8. The implantable device according to any one of claims 1 to 7, further programmed.   The one or more specific treatment modes are selected from the group comprising bradycardia pacing, cardiac resynchronization pacing, intermittent pacing therapy, contractility augmentation pacing, and neural stimulation. The implantable device according to claim 8.   10. Implantable device according to any one of the preceding claims, characterized in that the controller is programmed to increase the amplitude or duration of the stimulation pulse upon detection of inflammation.   The particular treatment mode is a contractile augmentation stimulus selected from the group comprising high volume pacing, anodic pacing, and refractory period stimuli, and the controller initiates the contractile augmentation stimulus upon detection of inflammation 11. Implantable device according to any one of the preceding claims, characterized in that it is programmed to increase or otherwise increase.   The particular treatment mode is intermittent stress enhanced pacing, and the controller is programmed to stop or otherwise reduce the degree of intermittent stress enhanced pacing upon detection of inflammation. The implantable device according to any one of claims 1 to 10.   The particular treatment mode is cardiac resynchronization pacing, and the controller is programmed to reoptimize pacing parameters selected from the group including an atrial-ventricular delay interval and a biventricular offset interval upon detection of inflammation. The implantable device according to claim 1, wherein the implantable device is a device.   The particular mode of treatment is a method of administering an anti-tachycardia therapy selected from the group comprising the delivery of cardioversion / defibrillation shock in response to tachycardia detection and the delivery of anti-tachycardia pacing; 11. The implant according to any one of claims 1 to 10, wherein the controller is programmed to lower a tachycardia threshold for detecting tachycardia upon detection of increased inflammation. Embedded device.   The particular mode of treatment is a method of administering an anti-tachycardia therapy selected from the group comprising the delivery of cardioversion / defibrillation shock in response to tachycardia detection and the delivery of anti-tachycardia pacing; 11. The implant according to any one of claims 1 to 10, wherein the controller is programmed to raise a tachycardia threshold for detecting tachycardia upon detection of reduced inflammation. Embedded device.

Images